NCT01331356已完成2 期
Prospective Multicenter Pilot Study Evaluating the Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia According to the Criteria of Rome III
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change from baseline in main score (SP) at 1 month
研究概览
简要总结
The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patient with chronic proctalgia according to the criteria of Rome III
- •Chronic or recurrent rectal pain
- •Pains evolve over periods of at least 20 minutes
- •With the exclusion of other causes of rectal pain: ischemic, inflammatory bowel disease, cryptic lesions, intramuscular abscess, anal fissure, hemorrhoids, prostatitis and isolated coccydynia
- •Pains evolve in a regular way since more than 3 months and the symptoms started since at least 6 months
- •These chronic proctalgia include syndromes of anus elevator and nonspecific functional anorectal pains
- •Patient with positive anesthetic block of ganglion Impar (minimum of 30 days before D0 and maximum of 270 days before D0)
- •Main score (SP) ≥ 4 before infiltration of botulinum toxin type A
- •Signed informed consent
- •Subjects affiliated with an appropriate social security system
排除标准
- •Pain related malignancy
- •Patients with bleeding risk and recent anticoagulant therapy
- •Surgery within 3 months
- •Pre-existing anal incontinence
- •Intolerance of botulinum toxin A, local anesthetics and radio contrast medium
- •Injection of botulinum toxin in any place whatsoever in the previous 3 months
- •Pregnancy and breast feeding
- •Antibiotic treatment by aminoglycosides
- •Recent anti-inflammatory treatment
- •Severe myasthenia
- •Lambert-Eaton syndrome
- •Patients with neurological disorders, dysphagia, food choking or inhalation pneumonia
研究组 & 干预措施
Injection of botulinum toxin type A
Experimental
干预措施: Botox (Drug)
结局指标
主要结局
Change from baseline in main score (SP) at 1 month
时间窗: one month
The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units) by calculating the main score (SP).
次要结局
- To assess the changing parameters of quality of life: global improvement score / treatment satisfaction assessed by digital scale, international pain scales (MPI, QDSA, QCD) / Beck score and Hospital Anxiety and Depression (HAD) score(6 month)
- To assess the duration of action of the product (main score SP)(6 month)
- To assess the adverse events(6 month)
- To assess the evolution of analgesics consumption(6 month)
研究者
研究点 (2)
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